Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01407406 | Phase 1 Study to Evaluate the PK, Safety, Tolerability of BIIB023 in Chinese, Japanese, and Caucasian Healthy Volunteers | PHASE1 | COMPLETED | 48 | — | — | Sep 1, 2011 | Feb 1, 2012 | Sep 16, 2013 | 2 | Australia, China |
| Arm | Type | Description |
|---|---|---|
| Chinese Subjects - low dose BIIB023 IV | EXPERIMENTAL | - |
| Chinese Subjects - high dose BIIB023 IV | EXPERIMENTAL | - |
| Japanese Subjects - low dose BIIB023 IV | EXPERIMENTAL | - |
| Japanese Subjects - high dose BIIB023 IV | EXPERIMENTAL | - |
| Causasian Subjects - low dose BIIB023 IV | EXPERIMENTAL | - |
| Caucasian Subjects - high dose BIIB023 IV | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BIIB023 - low dose IV Dose | DRUG | - |
| BIIB023 - high dose IV Dose | DRUG | - |
Inclusion Criteria: * Must have the ability to understand the purpose and risks of the study \& provide signed \& dated informed consent. * Chinese, Japanese or Caucasian subjects * Subjects of childbearing potential must practice effective contraception during the study and 3 months after their la...